Enteral feeding device and related methods of use

Abstract

Embodiments of the disclosure are drawn to an enteral feeding device for hydrolyzing triglycerides in a nutritional formula. The device may include a body housing a chamber, an inlet configured to fluidly couple with a source of nutritional formula, and an outlet configured to fluidly couple with an enteral feeding tube. The device may include a headspace and a plurality of particles contained within the chamber, wherein the lipase is covalently bonded to the plurality of particles. The device may include an inlet filter located between the inlet and the chamber, wherein the inlet filter contains a first plurality of openings, and an outlet filter located between the chamber and the outlet, wherein the outlet filter has a second plurality of openings smaller than the plurality of particles.

We claim: 
     
       1. An enteral feeding device for hydrolyzing triglycerides in a nutritional formula by exposing the nutritional formula to lipase, the device comprising:
 a body housing a chamber; 
 an inlet configured to fluidly couple with a source of nutritional formula, allowing the nutritional formula to enter the device from the source and flow into the chamber; 
 an outlet configured to fluidly couple with an enteral feeding tube, allowing the nutritional formula to exit the chamber and flow into the enteral feeding tube; 
 a plurality of particles contained within the chamber, wherein the lipase is bonded to the plurality of particles; 
 a headspace contained within the chamber defining a space not occupied by the plurality of particles; 
 an inlet filter located between the inlet and the chamber, wherein the inlet filter contains a first plurality of openings; and 
 an outlet filter located between the chamber and the outlet, wherein the outlet filter has a second plurality of openings, and wherein the second plurality of openings are smaller than the plurality of particles; 
 wherein the plurality of particles are configured to transition from a dry configuration to a wet configuration when exposed to the nutritional formula during an enteral feeding; 
 wherein, in the dry configuration, the plurality of particles have a moisture level of 0.1% to 5%, and wherein, in the wet configuration, the plurality of particles swell in volume by no more than 15%, thereby reducing the amount of headspace contained within the chamber; and 
 wherein the triglycerides in the nutritional formula are hydrolyzed as they pass through the plurality of particles contained within the chamber. 
 
     
     
       2. The device of  claim 1 , wherein the plurality of particles, when dry, fill at least 50% of the chamber. 
     
     
       3. The device of  claim 1 , wherein the plurality of particles, when dry, fill at least 80% of the chamber. 
     
     
       4. The device of  claim 1 , wherein the plurality of particles, when dry, fill at least 90% of the chamber. 
     
     
       5. The device of  claim 1 , wherein the plurality of particles, when exposed to the nutritional formula, fill at least 80% of the chamber. 
     
     
       6. The device of  claim 1 , wherein the plurality of particles, when exposed to the nutritional formula, fill at least 90% of the chamber. 
     
     
       7. The device of  claim 1 , wherein an outside surface of at least one of the plurality of particles is at least partially hydrophobic. 
     
     
       8. The device of  claim 1 , wherein at least one of the plurality of particles is formed of one or more of ethylene glycol dimethacrylate, butyl methacrylate, or glycidyl methacrylate. 
     
     
       9. The device of  claim 8 , wherein at least one of the plurality of particles is formed of 50% to 60% of ethylene glycol dimethacrylate by weight, 30% to 45% of butyl methacrylate by weight, and 0.01% to 10% of glycidyl methacrylate by weight. 
     
     
       10. The device of  claim 1 , wherein at least one of the plurality of particles is formed of 0% to 10% of polyethylene glycol by weight. 
     
     
       11. The device of  claim 1 , wherein at least one of the plurality of particles has a porous cross-section forming internal surfaces within the at least one particle. 
     
     
       12. The device of  claim 11 , wherein a median or a mean diameter of a pore of the porous cross-section ranges from 10 nm to 250 nm. 
     
     
       13. The device of  claim 11 , wherein the lipase is bonded to the internal surfaces. 
     
     
       14. The device of  claim 1 , wherein at least one of an outer surface or an internal surface of at least one of the plurality of particles includes a functional group. 
     
     
       15. The device of  claim 14 , wherein the functional group is an epoxy group, and the lipase is bonded to the epoxy group. 
     
     
       16. The device of  claim 1 , wherein a median or a mean diameter of the plurality of particles ranges from 250 μm to 800 μm. 
     
     
       17. The device of  claim 1 , wherein the plurality of particles comprises a first group of particles and a second group of particles, wherein the first group of particles has a median or a mean diameter that is different than a median or a mean diameter of the second group of particles. 
     
     
       18. The device of  claim 1 , wherein an amount of the lipase bonded to the plurality of particles falls within a range of 50 mg to 250 mg of lipase per 1 g of the plurality of particles. 
     
     
       19. The device of  claim 1 , wherein at least one of the first plurality of openings or the second plurality of openings includes a plurality of tortuous paths. 
     
     
       20. The device of  claim 1 , wherein the inlet filter is coated with at least one emulsifier configured to emulsify the nutritional formula as it passes through the inlet filter. 
     
     
       21. The device of  claim 1 , wherein the inlet filter and the outlet filter each have a thickness of 0.1 mm to 10 mm. 
     
     
       22. The device of  claim 1 , wherein the lipase bonded to the plurality of particles has a purity of at least 25%. 
     
     
       23. An enteral feeding device for hydrolyzing triglycerides in a nutritional formula by exposing the nutritional formula to lipase, the device comprising:
 a body housing a chamber, the chamber comprising:
 a plurality of porous particles contained within the chamber, wherein the lipase is bonded to the plurality of particles, wherein the plurality of particles have an average diameter of 250 μm to 800 μm, and wherein pores in the plurality of particles have a median or a mean diameter of 10 nm to 250 nm; and 
 a headspace contained within the chamber defining a space not occupied by the plurality of particles; 
 
 a first connector configured to fluidly couple the device with a first tube; 
 an inlet positioned between the first connector and the chamber and fluidly coupled with the first connector and the chamber; 
 a second connector configured to fluidly couple the device with a second tube; 
 an outlet positioned between the second connector and the chamber and fluidly coupled with the chamber and the second connector; and 
 an outlet filter located between the chamber and the outlet, wherein the outlet filter has a plurality of openings, and wherein the plurality of openings are smaller than the plurality of particles; 
 wherein the plurality of particles are configured to transition from a dry configuration to a wet configuration when exposed to the nutritional formula during an enteral feeding; 
 wherein, in the dry configuration, the plurality of particles have a moisture level of 0.1% to 5%, and wherein, in the wet configuration, the plurality of particles swell in volume by no more than 15%, thereby reducing the amount of headspace contained within the chamber; and 
 wherein the triglycerides in the nutritional formula are hydrolyzed as they pass through the plurality of particles contained within the chamber. 
 
     
     
       24. The device of  claim 23 , wherein the lipase bonded to the plurality of particles has a purity of at least 25%. 
     
     
       25. The device of  claim 23 , wherein an amount of the lipase bonded to the plurality of particles falls within a range of 50 mg to 250 mg of lipase per 1 g of the plurality of particles. 
     
     
       26. An enteral feeding device comprising:
 a body housing a chamber; 
 a plurality of porous particles contained within the chamber, wherein the plurality of particles have an average diameter of 250 μm to 800 μm, and wherein pores in the plurality of particles have a median or a mean diameter of 10 nm to 250 nm; 
 lipase bonded to the plurality of particles, wherein an amount of the lipase bonded to the plurality of particles falls within a range of 50 mg to 250 mg of lipase per 1 g of the plurality of particles, and wherein the lipase bonded to the plurality of particles has a purity of at least 25%; 
 a headspace contained within the chamber defining a space not occupied by the plurality of particles; 
 a first connector configured to fluidly couple the device with a first tube; 
 a second connector configured to fluidly couple the device with a second tube; 
 an inlet filter; and 
 an outlet filter; 
 wherein the plurality of particles are configured to transition from a dry configuration to a wet configuration when exposed to the nutritional formula during an enteral feeding; and 
 wherein, in the dry configuration, the plurality of particles have a moisture level of 0.1% to 5%, and wherein, in the wet configuration, the plurality of particles swell in volume by no more than 15%, thereby reducing the amount of headspace contained within the chamber.